Unicycive Therapeutics, Inc. (UNCY) on Monday said it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis.
The NDA was resubmitted following progress by the company's original third-party manufacturing vendor in addressing deficiencies cited by the FDA and demonstrating inspection readiness. The application had previously received a Complete Response Letter (CRL) in June 2025, which identified a single issue related to the vendor's compliance status.
"Our original third-party manufacturing vendor has made significant progress toward regaining FDA compliance, allowing us to resubmit the OLC NDA as planned," said Chief Executive Officer Shalabh Gupta, M.D. He added that with a cash runway extending into 2027, the company is positioned to complete the regulatory process and prepare for a potential launch of OLC for dialysis patients with hyperphosphatemia.
https://www.nasdaq.com/articles/unicycive-resubmits-nda-oxylanthanum-carbonate-fda
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